Innovation News

Trenton, NJ - Bolstered by State resources,Celator Pharmaceuticalshas raised capital to fund operations and is nearing the completion of a Phase 3 clinical trial for its lead product that,if successful, could lead to approval in the company’s global fight toimprove cancer patients’ outcomes.

Ewing-based Celator Pharmaceuticals, which has a workforce in both New Jersey and Canada, is currently in the last stage of clinical tests for its lead asset, VYXEOSTM(CPX-351). The injected therapy treats patients with high-riskacute myeloid leukemia (AML), a type of cancer in which the bone marrow makes abnormalmyeloblasts (a type of white blood cell), red blood cells, or platelets.CPX-351 has received orphan drug status from both the United States Food Drug Administration (FDA) and the European Commission (EC);an orphan drug is a pharmaceutical agent that has been developed specifically to treat a rare medical condition, such as AML.Results of the study are expected to be announced early next year, with aNewDrugApplication expected to be filed with theFDAin the second half of 2016.

Celator has benefited on multiple occasions from the State’sTechnology Business Tax Certificate Transfer (NOL) Program, which allows eligible technology and biotechnology companies with fewer than 225 employees to sell a portion of their net operating losses.Since the program was established in 1999, more than 500 different businesses have been approved for awards totaling more than $800 million. At its August Board meeting, the New Jersey Economic Development Authority (EDA) approved more than three dozen companies to share the Fiscal Year 2016 NOL funding allotment. The names of those companies will be made public later this year, following the conclusion of the NOL appeals process.@NJEDATech spoke with Celator ChiefExecutiveOfficerScott Jackson about his company’s experience in New Jersey:

Why did you choose to grow Celator in New Jersey? New Jersey is an excellent location for multiple reasons: the healthcare talent base in the area is exceptional; the focus and assistance provided by the state has significantly helped Celator, as well as other companies, advance novel products for patients;andthe state is home to numerous pharmaceutical and biotechnology companies, foundations and world-renowned research organizations. These factors, along with the benefits provided by other organizations such as BioNJ, are key reasons why we chose to grow Celator in New Jersey.

How did Celator benefit from funding it received through State resources? We first participated in the NOL program in 2009. Through the years, the program has provided a substantial amount of funding to the company -- approximately $8 million over that period of time. With most biotechnology companies, funding is critical, particularly in the early years, and funds from the NOL accounted for approximately 10% of our operating budget during that period of time. This funding helped the company advance our lead product candidate, VYXEOS™ (CPX-351) to the last stage of clinical testing, Phase 3, as a treatment for patients with AML. In addition, we have been able to advance our proprietary technology platforms.

In addition, the EDA invested in Celator through its limited partnership in the Garden State Life Sciences Venture Fund, managed by Quaker BioVentures. Celetor was able to leverage resources provided through the Fund to advance both our proprietary technology platform as well as the clinical development of VYXEOS.

What is Celator’s biggest success to date? As I mentioned, VYXEOS is in a Phase 3 clinical trial in patients with AML. We expect the overall survival result from this study in the first quarter of 2016 and we’re targeting aNewDrugApplication for the third quarter of 2016.

The standard of care for AML patients has not changed in roughly 40 years. In Phase 2 studies, we saw improvement in remission rates, reduction in early mortality, improvement in event-free survival and overall survival. In high-risk patients, such as those with secondary AML and poor-risk first relapse AML, the overall survival improvements were statistically significant. Based on these results, we advanced VYXEOS into a Phase 3 trial in patients with high-risk (e.g. secondary) AML. VYXEOS has the potential to become the new foundation of care for AML patients.

We are also fortunate to have the Leukemia and Lymphoma Society® (LLS) as a partner. LLS partnered with Celator in the development of VYXEOS starting in Phase 2 and based on the results seen in those studies, LLS agreed to provide additional support for the Phase 3 trial. VYXEOS is based on one of our proprietary technology platforms, called CombiPlex®. CombiPlex addresses several fundamental shortcomings of conventional combination drug regimens by identifying the most effective synergistic ratio of the drugs being combined and fixing the ratio in a nano-scale delivery complex to maintain the optimized combination,in patients, until exposure to the tumor with the goal of improving clinical outcomes.